Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT06701760
Eligibility Criteria:
Inclusion Criteria:
GCS at enrollment 3-8; Male or female aged 18-80 at admission; acute positive CT findings; ability for subject to comply with the requirements of the study; and written informed consent obtained from subject or subject's legal representative.
Exclusion Criteria:
Penetrating TBI, Polytrauma leading to instability of systemic hemodynamics, acidosis, or severe acute lung injury during the inclusion period. History of neurological disease, including Parkinson's, Huntington's, Alzheimer's, etc.; History of diabetes mellitus; Serum sodium ≥ 148 mM; Metabolic acidosis pH \<7.34; Coagulopathy INR \> 1.3, platelets \< 100,000, or hematocrit \< 28 mg/dl; Renal insufficiency with GFR \< 60% of expected or Cr \> 1.3; AST or ALT \> 1.5x upper limit of normal; Severe liver trauma; baseline serum lactate \> 2 mM; Hypotension SBP \< 90 refractory to vasopressors; Known mitochondrial genetic disorder; Pregnancy; Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data; Member of a protected population; simultaneous participation in another randomized trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06701760
Study Brief:
Protocol Section:
NCT06701760